Hi,
I've been a trainer for about 7 years now and have a new position in the QA department of a large research project. Because of my training experience I have been provided the responsibility of reviewing the training of the employees (about 8 years worth) and strengthen their "program".
I'm totally new to working within the guidance of FDA and within GMP, so please bear with me.
I guess my question is: If there is a meeting where deviations are discussed and the staff are reminded of the proper procedure during this meeting....is this a training session? I'm seeing a lot of this in the employees' records.
Thanks!
d

I have no knowledge of the specific industry you are working in, but I don't think I would call this training. It sounds more like a quality calibration session. You aren't emparting new skills, or adding to the skill set of the employees. You are only reminding them of things they already know. It doesn't pass the sniff test in my opinion.

Thanks! those are my thoughts - EXACTLY. I'm having a difficult time with the management with regard to what "trainig" actually is or does.

The comment - "...emparting new skills or adding to a skill set" is perfect!

Thanks!

anyone else? specifically someone who works within GMP regs? Would you document a meeting that discusses deviations and the corrective action as a training?

This message has been edited. Last edited by: dstoeck,

I was in Biotech QA for several years and also a trainer. I have seen that try and be passed off as training, and ultimately, it depends on the deviation and the SOP. If it is a very minor infraction, like the date format was documented incorrectly, this might be enough of a corrective action to show that the person was "retrained" in the proper documentation of the date format.

However, in anything much more than that, this would not qualify as a training session at all. It's a very difficult sell for the QA/training person to get management to agree that more is needed, as they are under deadlines to do corrective actions and close the deviations quickly, per FDA guidelines. But this sort of training would not withstand an FDA inspection, so that is something to keep in mind and use as part of your argument.

Unfortunately, there is no black and white approach to corrective actions for deviations. If you can find a QA person that you can consult with who has experience with deviations and corrective actions within your company, that might help you better understand the culture you're dealing with from this aspect (the QA aspect), as it is different from what you have been working with in the past.

Hope that helps a bit.

Thanks for your reply! I do appreciate others taking time to help me with this.
My supervisor is a Six Sigma certified GMA-type person. I come from the world of EPA - Regulatory Environmental Science and now in the world of biologics.

I guess I need to develop my argument that "telling" employees of a minor change in an SOP is not training. That would fall under the category of "We keep our employees informed of changes to SOPs". Reminding employees to follow SOPs is not a training. That is a warning or a management item. Training is when there is a significant change to an SOP where the procedure is changed.

Thanks so much!